Necessary,Important,and Room for Improvement: Researcher Perspectives on the Impacts of the Select Agent Regulations on Vaccine Development

Abstract

Introduction:

In the United States, vaccine development is a complicated and multifaceted process governed by a myriad of regulatory authorities and structures. In addition to industry laboratory, clinical, and manufacturing best practices, biosecurity restrictions are also placed on vaccine development for “select agents,” those agents that are considered to pose the greatest risk to public health. Regulations imposed on select agent vaccine development must necessarily be adaptable in consideration of the opinions and experiences of practitioners, but, to date, those involved in vaccine development for select agents have not been specifically represented in published studies assessing researcher viewpoints. The perspectives of this community thus represent a gap in our knowledge of the effects of regulations on biosecurity preparedness infrastructures.

Objectives:

In this study, we sought to capture personal experiences of scientists working on select agent vaccines, who face unique technical considerations that differ from other vaccine research.

Methods:

We interviewed U.S. Government researchers and independent contractors who are directly involved in creating vaccines to assess how the select agent regulations (SARs) affect vaccine development in the United States. These personal narratives were transcribed and compiled thematically, covering topics of financial and governmental incentives, administrative and regulatory challenges, subcontracting, personnel security measures, and safety and efficacy testing.

Results:

Across eight interviews, there was a consensus that the SARs, while burdensome, are fair provisions that mitigate the inherent risk of conducting select agent work. Their perspectives exhibited how the SARs are primarily relevant during the preclinical stage of vaccine development and generally restrict progression to later stages of development typical of nonselect agent vaccines. In addition, lacking government financial incentives, the need for subcontracting, and the limited availability of validated animal models, while not exclusive to SAR work, all serve as significant obstacles to researcher involvement and overall progress in select agent vaccine development.

Conclusions:

Collectively, these perspectives provide valuable insight into the strengths, weaknesses, and potential areas for improvement in the implementation of the SARs for select agent vaccine development. In addition, these accounts were complimentary of the SARs in ways not currently represented in the literature, which merits further evaluation by larger-scale studies of this subgroup as well as select agent researchers as a whole. These insights provide important context for future discussions of regulatory oversight and its impact on biosecurity preparedness.